Active Pharmaceutical Ingredient

Ranitidine

Also known as: Zantac; Ranitidine HCl; Tritec

CAS: 66357-35-5 H2-Blocker IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Ranitidine API — Mediocon Inc
Ranitidine — Pharmaceutical Grade API

Product Overview

CAS No: 66357-35-5  |  MF: C₁₃H₂₂N₄O₃S  |  MW: 314.40 g/mol

Ranitidine is a pharmaceutical-grade active ingredient classified as an H₂ Receptor Antagonist Antiulcer agent. Mediocon Inc supplies high-purity Ranitidine API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Ranitidine is an H2-receptor antagonist that competitively inhibits histamine at the H2 receptors of gastric parietal cells, reducing basal and stimulated acid secretion. It is used in the treatment of peptic ulcers, gastroesophageal reflux disease, and Zollinger-Ellison syndrome. Ranitidine HCl is the pharmaceutical salt form widely used in tablet and injection formulations.

Key Features

  • High-purity pharmaceutical grade API
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Duodenal and gastric ulcer treatment
  • GERD and erosive esophagitis
  • Zollinger-Ellison syndrome
  • Prevention of stress-related mucosal bleeding

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameRanitidine
Also Known AsZantac; Ranitidine HCl; Tritec
CAS Number66357-35-5
Molecular FormulaC₁₃H₂₂N₄O₃S
Molecular Weight314.40 g/mol
CategoryH₂ Receptor Antagonist — Antiulcer
AppearanceWhite to pale yellow crystalline powder
SolubilityFreely soluble in water; soluble in ethanol
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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